Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOV
Summary
The FDA issued a Class II for Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NO by Covidien, LP. Reason: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact.
Details
Source
Device Recall
External ID
Z-1175-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6 8886 4410-13 NOVAFIL 6-0 BLU 45CM P10 8886 4410-03 NOVAFIL 7-0 BLU 45CM P10 8886 4422-43 NOVAFIL 3-0 BLU 45CM C14 8886 4424-51 NOVAFIL 2-0 BLU 75CM C16 8886 4450-41 NOVAFIL 3-0 BLU 75CM V26 8886 4452-51 NOVAFIL 2-0 BLU 75CM V20 8886 4459-61 NOVAFIL 0 BLU 75CM GS22 8886 4470-81 NOVAFIL* 2 BLU 150CM GS26 8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14 SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12 SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12 SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12 SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12 SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12 SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13 SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12 SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12
Lot/Code Info: GTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY
Quantity Affected: 48492 units
Reason for Recall
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Distribution
US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-02
Company
North Haven, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1175-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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